Product code LOM— Microbiology
LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
- Classification name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Device class
- Class 2
- Regulation
- 21 CFR 866.3172
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.”
Market context for product code LOM
FDA has cleared device under product code LOM, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code LOM
Adverse events under product code LOM
product code LOM- Malfunction
- 1,251
- Total
- 1,251
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LOM
Data sourced from openFDA. This site is unofficial and independent of the FDA.